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Coherus Oncology, Inc. reports commercial-stage oncology developments centered on LOQTORZI® (toripalimab-tpzi), an approved next-generation PD-1 inhibitor for recurrent or metastatic nasopharyngeal carcinoma. Company updates also cover its antibody immunotherapy pipeline, including tagmokitug, an anti-CCR8 cytolytic antibody, and casdozokitug, an IL-27 antagonistic antibody, across solid-tumor programs such as liver, prostate, head and neck, colorectal, gastric and esophageal cancers.
Recurring news includes financial results, LOQTORZI revenue commentary, clinical-development updates, strategic partnerships, investor-conference presentations, public common-stock offerings, debt reduction and other capital-structure actions tied to the company's transition from biosimilars to innovative oncology.
Coherus BioSciences, Inc. (NASDAQ: CHRS) has appointed Charlie Newton, a notable biotech strategist and CFO, to its Board of Directors. With nearly three decades of experience in healthcare investment banking, Newton is expected to enhance Coherus' immuno-oncology strategy. CEO Denny Lanfear recognizes his expertise in building shareholder value. Coherus is focusing on capitalizing on its commercial portfolio and advancing its pipeline, including a resubmission of a BLA for toripalimab to treat advanced nasopharyngeal carcinoma by mid-summer 2022.
Coherus BioSciences (CHRS) announced on April 27, 2022, the granting of stock options to 13 new employees totaling 240,000 shares. The options have an exercise price of $9.28, matching the closing trading price on that date. Among the granted options, two Vice Presidents received 45,000 shares each, while another received 50,000 shares. The remaining 100,000 shares were allocated to ten non-officer employees. This initiative is part of the 2016 Employment Commencement Incentive Plan to attract new talents to the company.
Coherus BioSciences (Nasdaq: CHRS) and Junshi Biosciences announce the FDA's complete response letter (CRL) regarding their Biologics License Application (BLA) for toripalimab, aimed at treating advanced nasopharyngeal carcinoma (NPC). The CRL requests a quality process change, which both companies believe is manageable. They plan to resubmit the BLA by mid-summer 2022, followed by a six-month FDA review timeline. Inspections in China for FDA approval are delayed due to COVID-19 restrictions. If approved, toripalimab will be the first immuno-oncology agent for NPC in the U.S.
Coherus BioSciences (Nasdaq: CHRS) has announced that its first quarter 2022 financial results will be released after market close on May 5, 2022. A conference call will follow at 4:30 p.m. ET, where management will discuss the results and provide a business update. The corrected press release highlighted the new start time for the call, which was previously misstated. Interested parties can access the webcast and financial results on the company’s investor relations website.
Coherus BioSciences (CHRS) will release its first quarter 2022 financial results on May 5, 2022, after market close. Following the announcement, management will host a conference call at 5 p.m. ET to discuss the results and provide a business update. Interested parties can access the call by dialing (844) 452-6826 for U.S. and Canadian callers or (765) 507-2587 internationally. A replay will be available on the company's website for 30 days following the event.
Coherus BioSciences (Nasdaq: CHRS) and Shanghai Junshi Biosciences announced that the FDA has granted Orphan Drug Designation for toripalimab, a PD-1 inhibitor, for small cell lung cancer (SCLC). This designation, meant for rare diseases, aims to boost the drug's development and commercialization. SCLC has a poor prognosis, with a five-year survival rate of around 20%. The ongoing JUPITER-08 Phase 3 trial is assessing toripalimab combined with chemotherapy as a first-line treatment for extensive stage SCLC. Topline data is expected later this year.
Coherus (CHRS) and Junshi Biosciences announced significant results from the JUPITER-02 study, a Phase 3 trial assessing toripalimab with chemotherapy for advanced nasopharyngeal carcinoma (NPC).
The trial revealed a median progression-free survival (PFS) of 21.4 months for the toripalimab group versus 8.2 months for placebo, showing a strong statistical significance. Interim overall survival (OS) data indicates a 41% reduced risk of death.
The FDA has granted breakthrough therapy designation for toripalimab, with a biologics license application currently under priority review.
Coherus BioSciences (NASDAQ: CHRS) announced on April 5, 2022, that it granted stock options for 461,000 shares to newly hired employees as of March 31, 2022. These options have an exercise price of $12.91, aligned with the closing price on the grant date. A Chief level executive received options for 200,000 shares and 50,000 restricted stock units, while 18 non-officer employees were awarded options for a total of 261,000 shares. This move aims to attract new talent under the 2016 Employment Commencement Incentive Plan approved by the Company’s board.
Coherus BioSciences, Inc. (CHRS) is positioning itself for long-term growth by targeting $1.2 billion in annual net sales by 2026. The company is advancing its immuno-oncology pipeline, focusing on its PD-1 inhibitor, toripalimab, which is under FDA review for nasopharyngeal carcinoma. Upcoming product launches include CIMERLI, a Lucentis biosimilar, and YUSIMRY, a Humira biosimilar. Coherus plans to leverage existing commercial infrastructure for these launches, aiming for significant shareholder value creation.
Coherus BioSciences (Nasdaq: CHRS) announced an Analyst Day set for March 29, 2022, at 9:30 a.m. ET in New York City. The event will focus on prospective product launches over the next 15 months, along with updates on the company’s entry into immuno-oncology with PD-1 inhibitor toripalimab and combination therapies. The FDA is reviewing toripalimab for nasopharyngeal carcinoma, with a decision expected by April 30, 2022. Additionally, Coherus plans to launch its Humira biosimilar in 2023 and is pursuing various biosimilars in development.